Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index

Hypotension Clinical Trial

Official title:

Pleth Variability Index Predicts Hypotension in Beach Chair Position in Mechanically Ventilated Adults During General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02527538
• Other study ID #: C2013209(1169)
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2015
• Last updated: January 26, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Chung-Ang University Hospital
• Contact: Yong-Hee Park, M.D.
• Phone: +82-2-6299-3207
• Email: dada822[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth variability may predict the hypotension during beach chair position.

Description:

The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The investigators put the masimo probe before general anesthesia and recorded the values before and after beach chair position, The values include arterial pressure, heart rate, blood pressure, perfusion index, pleth variability index.

The primary end point was the predictive value and threshold or pleth variability index for hypotension induced by the beach chair position. The occurrence of hypotension was counted by using vasopressor. The use of vasopressor was performed when mean blood pressure less than 65 mmHg or 20% of baseline.

The investigators planned to recruit 57 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• elective shoulder surgery under general anesthesia

Exclusion Criteria:

• right heart failure

• morbid obesity (BMI > 30)

• arrhythmia on preoperative electrocardiography

• pulmonary hypertension

• peripheral vascular disease or pulmonary disease

• pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• Pleth
apply the masimo probe on index fingertip and record the pleth variability and blood pressure during beach chair position

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Siswojo AS, Wong DM, Phan TD, Kluger R. Pleth variability index predicts fluid responsiveness in mechanically ventilated adults during general anesthesia for noncardiac surgery. J Cardiothorac Vasc Anesth. 2014 Dec;28(6):1505-9. doi: 10.1053/j.jvca.2014.04.010. Epub 2014 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of hypotension defined as mean blood pressure less than 65 mmHg or 20% of baseline	hypotension occurs or not after beach chair position and hypotension was defined as mean blood pressure less than 65 mmHg or 20% of baseline	10 minutes after beach chair position	No